Calendario›SNY›Isatuximab · ICARIA-MM
Isatuximab · ICARIA-MM
Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
Ensayo de Sanofi en Plasma Cell Myeloma (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 307
- Centros
- 111
- Fin del objetivo primario
- nov 2018
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en dic 2016.
Qué mide
Progression Free Survival (PFS) (From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration: 76.7 weeks)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM). Secondary Objectives: * To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm. * To compare the Overall Survival (OS) between the two arms. * To evaluate the Time To Progression (TTP) in each arm. * To evaluate the PFS in high risk cytogenetic population in each arm. * To evaluate the Duration of Response (DOR) in each arm. * To evaluate the safety in both treatment arms. * To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide. * To evaluate the immunogenicity of isatuximab. * To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02990338), actualizada en ene 2025.